In the latest dispute surrounding the “patent dance” provisions of the Biologics Price Competition and Innovation Act (BPCIA), Genentech, Inc. has filed a complaint against Amgen, Inc., alleging that after opting into the BPCIA’s information exchange procedures, Amgen withheld relevant confidential information and unreasonably refused expert consultant review of Amgen’s Abbreviated Biologic License Application (aBLA). This case is not the first to highlight the difficulties with a statutory scheme that requires fierce competitors to share highly confidential information, but may lead to the first decision on just how much information a biosimilar applicant has to disclose and to whom. Continue reading this entry
The Federal Circuit focused on the “consisting of” language in the claims at issue when it reversed the district court’s finding that Watson’s ANDA product would infringe the only Orange Book-listed Shire Lialda patent. In so doing, the court emphasized the narrow scope of the Norian exception to the “closed” nature of “consisting of” language that applies only for “aspects unrelated to the invention.”
The Federal Circuit decision in Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC may be more interesting for what Mylan argued than for what the Federal Circuit decided. However, it could be an important decision for pharmaceutical companies who need to innovate in order to satisfy FDA requirements. Continue reading this entry
In Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., the Federal Circuit affirmed the district court decision finding infringement under Akamai of a two-step method of treatment when the prescribing information for the prescription drug component required coadministration of the other active agent. The appeal arose from ANDA litigation surrounding Eli Lilly’s ALIMTA® product, which is to be taken with folic acid and vitamin B12 to reduce side effects. Although pharmaceutical companies may welcome this decision, they should be aware of the emphasis the court place on the specific guidance and instructions provided in the product labeling. Continue reading this entry
President-elect Trump’s plans for his first 100 days in office include “cutting the red tape at the FDA” and “speed[ing] the approval of life-saving medications.” Here, we consider specific steps Trump could take–without or with Congressional approval.